FDA recall D-0794-2022

Product

Lidocaine 2.5% and Prilocaine 2.5% Cream, USP, packaged in a) 5 g tubes (NDC 0591-2070-72), b) 30 g tubes (NDC 0591-2070-30), Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA

Reason for recall

cGMP Deviations

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2022-04-15

Report date

2022-05-04

Termination date

2023-05-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0794-2022